Intractable PainPhase 4KETAREFNCT02587130
Ketamine and Refractory Painful Care in a Palliative Unit
A Phase 4 study testing Ketamine in people with Intractable Pain and Intensive Care, run by Lille Catholic University at 1 site in France.
Trial summary
Pain is one of the major symptoms in palliative care units and often is very difficult to treat, being considered as a refractory pain. There are different causes of refractory pain: pain due to bed sores and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Pain, Intensive Care, Pressure Ulcer
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to 10 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of ≥18 years old, hospitalized in palliative care units
- Conscious or presenting altered/disturbed consciousness but for whom the Rudkin score is ≤ 4 (eyes closed, response to light tactical stimulation)
- For whom a palliative care is acted
- No matter the progression and prognostic status
- After the information is given to the patient (with the notification form given) and the written consent form is retrieved and when the state of cognition and vigilance allows it. In case of cognitive and consciousness disturbance, after informing and retrieving the written consent form from the patient's trusted person, or a relative by default, for patients under guardianship after being informed and giving a consent form written by the legal representative.
- Evened out on an analgesia level, without care
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- Who has not received ketamine for 60 days before inclusion no matter the indications
- For whom bedsore, ulcer or vascular injuries have appeared and continue to be painful despite the administration of opioid bolus with the painful evaluation regarding the visual analogic scale (EVA) ≥ 5/10, or regarding the evaluation of the Algoplus pain behavior scale ≥ 2, or for whom the opioid treatment cannot be administered due to the presence of adverse side effects (drowsiness, confusion, nausea, vomiting, respiratory depression…)
- And for whom caring under Entonox (a medical analgesic gas which is a mix of nitrous oxide and oxygen) is inefficient or not compatible.
- Lack of easy venous access
Who cannot join
- Contraindication of Ketamine in case of anesthesia (AMM) : allergy, porphyria
- Late stage heart failure
- Intracranial hypertension
- Acute heart attack phase
- Unstable psychosis
- Presence of agitation
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- Pregnant woman
- Patient with no affiliation to a social security system
- Contraindication of Midazolam: known hypersensitivity to benzodiazepines or any other know excipient of the product, acute respiratory depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect and Tolerance of a Ketamine Subcutaneous Bolus, During Painful Care of Refractory Bed Sores, Ulcers and Vascular Wounds in a Palliative Care Unit
Pain is one of the major symptoms in palliative care units and often is very difficult to treat, being considered as a refractory pain.
There are different causes of refractory pain: pain due to bed sores and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain due to traumatological injuries, pain associated with a long-term bed confinement, etc.
The investigators propose a prospective study to estimate the effect and the tolerance to a subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care units.
Read the detailed description
Patients in palliative care units have serious and incurable conditions and are in the sickness' late or final stages. This is why the relief of their symptoms is a priority for their medical care, being pain one of the major symptoms.
In this context, the idea of treating various types of pain such as pain due to bed sore and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, etc. was raised.
French Ministry of Health's 2010 recommends the use of ketamine to treat refractory pain after the failure of usual therapeutic treatments (opioids, Nitrous oxide and oxygen (also known as MEOPA)). This treatment is then used in association with midazolam (0.01 to 0.05 mg/kg) to prevent hallucinating effects.
However, the intravenous treatment is often the alternative and this choice is justified by the study population's characteristics (usually elderly patients, multi-pathologic, etc) and by the invasive way of treatment used with a repeated central and peripheral venous catheters which is contrary to the primary objective of patient comfort.
To the investigators' knowledge, no randomised study has ever been done regarding the use of ketamine to treat refractory pain administered subcutaneously.
- Conditions
- Intractable Pain, Intensive Care, Pressure Ulcer, Pain Management
- Being tested
- Ketamine
- Keywords
- intractable pain, pressure ulcer, bed sore, palliative medicine, ketamine, pain management
- Medical subject headings
- Pain, Intractable, Pressure Ulcer, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
ketamine administered in bolus by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| communicating and none-communicating patients | Experimental | 20 communicating patients (evaluated with the visual analogue pain scale (VAS)) and 20 none-communicating patients or patients presenting cognitive disturbance or vigilance (evaluated with the Algoplus scale) Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain Score on the Visual Analog Scale or Algoplus after subcutaneous bolus of Ketamine
Evaluate the symptomatic effect on pain and the comfort of ketamine's sub-cutaneous bolus administered to adults hospitalized in palliative units during painful care of vascular wounds, ulcers and bedsores, not eased by opioid or Entonox (a medical analgesic gas which is a mix of nitrous oxide and oxygen) or for whom these treatments are not adapted (Entonox, in cases of disturbed consciousness) or for whom side effects are unbearable (drowsiness, confusion, nausea, vomiting, respiratory depression…). Two kind of scores will be analyzed (EVA and Algoplus).
Measured: 2 hours
Secondary outcomes (2)
Number of secondary side effects after administration of a sub-cutaneous ketamine's bolus
Evaluate the tolerance of the sub-cutaneous administration of ketamine's bolus, with protocol dosages and with the surveillance of:
- Arterial pressure, heart frequency, respiratory frequency, saturation in visual oxygen
- The appearance of neuroleptic symptoms: confusion, perturbation of visual/hearing sensations, humor perturbation, hallucinations, agitation…
- Appearance of hypersialorrhea, bronchial cluttering
- Presence of nausea or vomiting
- Presence of cephalgia or dizziness
Measured: 2 hours
Ketamine dosage administered in sub-cutaneous bolus before painful caring
Define a ketamine dosage administered in sub-cutaneous bolus, before painful caring in order to obtain the antalgic efficacy thanks to EVA < 3 or Algoplus scale < 2, and in a satisfactory efficacy/tolerance report for patients' comfort.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startMay 2016
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Why it stopped: difficulted recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Danel Delerue, MD, Principal investigator, Groupment des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587130
- Sponsor's protocol ID
- RC-P0041
- Acronym
- KETAREF
- Status last verified
- Feb 2020
- First submitted
- 13 Oct 2015
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Tolerance of a Ketamine Subcutaneous Bolus, During Painful Care of Refractory Bed Sores, Ulcers and Vascular Wounds in a Palliative Care Unit
- ClinicalTrials.gov ID
- NCT02587130
- Acronym / sponsor ID
- KETAREF / RC-P0041
- Conditions
- Intractable Pain, Intensive Care, Pressure Ulcer, Pain Management
- Keywords
- intractable pain, pressure ulcer, bed sore, palliative medicine, ketamine, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulted recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain is one of the major symptoms in palliative care units and often is very difficult to treat, being considered as a refractory pain.
There are different causes of refractory pain: pain due to bed sores and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain due to traumatological injuries, pain associated with a long-term bed confinement, etc.
The investigators propose a prospective study to estimate the effect and the tolerance to a subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care units.
Detailed description
Patients in palliative care units have serious and incurable conditions and are in the sickness' late or final stages. This is why the relief of their symptoms is a priority for their medical care, being pain one of the major symptoms.
In this context, the idea of treating various types of pain such as pain due to bed sore and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, etc. was raised.
French Ministry of Health's 2010 recommends the use of ketamine to treat refractory pain after the failure of usual therapeutic treatments (opioids, Nitrous oxide and oxygen (also known as MEOPA)). This treatment is then used in association with midazolam (0.01 to 0.05 mg/kg) to prevent hallucinating effects.
However, the intravenous treatment is often the alternative and this choice is justified by the study population's characteristics (usually elderly patients, multi-pathologic, etc) and by the invasive way of treatment used with a repeated central and peripheral venous catheters which is contrary to the primary objective of patient comfort.
To the investigators' knowledge, no randomised study has ever been done regarding the use of ketamine to treat refractory pain administered subcutaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| communicating and none-communicating patients | Experimental | Drug: Ketamine20 communicating patients (evaluated with the visual analogue pain scale (VAS)) and 20 none-communicating patients or patients presenting cognitive disturbance or vigilance (evaluated with the Algoplus scale) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients of ≥18 years old, hospitalized in palliative care units
- Conscious or presenting altered/disturbed consciousness but for whom the Rudkin score is ≤ 4 (eyes closed, response to light tactical stimulation)
- For whom a palliative care is acted
- No matter the progression and prognostic status
- After the information is given to the patient (with the notification form given) and the written consent form is retrieved and when the state of cognition and vigilance allows it. In case of cognitive and consciousness disturbance, after informing and retrieving the written consent form from the patient's trusted person, or a relative by default, for patients under guardianship after being informed and giving a consent form written by the legal representative.
Key exclusion criteria (9 listed)
- Contraindication of Ketamine in case of anesthesia (AMM) : allergy, porphyria
- Late stage heart failure
- Intracranial hypertension
- Acute heart attack phase
- Unstable psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamineketamine administered in bolus by subcutaneous injection | Drug | communicating and none-communicating patients |
Primary outcome
Change from Baseline in Pain Score on the Visual Analog Scale or Algoplus after subcutaneous bolus of Ketamine
Time frame: 2 hours
Evaluate the symptomatic effect on pain and the comfort of ketamine's sub-cutaneous bolus administered to adults hospitalized in palliative units during painful care of vascular wounds, ulcers and bedsores, not eased by opioid or Entonox (a medical analgesic gas which is a mix of nitrous oxide and oxygen) or for whom these treatments are not adapted (Entonox, in cases of disturbed consciousness) or for whom side effects are unbearable (drowsiness, confusion, nausea, vomiting, respiratory depression…). Two kind of scores will be analyzed (EVA and Algoplus).
2 secondary outcomes
Number of secondary side effects after administration of a sub-cutaneous ketamine's bolus
Time frame: 2 hours
Ketamine dosage administered in sub-cutaneous bolus before painful caring
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: difficulted recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Danel Delerue, MD principal investigator
Groupment des Hôpitaux de l'Institut Catholique de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Intractable Pain and Intensive Care, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficulted recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain Score on the Visual Analog Scale or Algoplus after subcutaneous bolus of Ketamine (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.